CDRHNew - News and Updates
August 1, 2022
- Consumer Information on: TactiCath Contact Force Ablation Catheter, Sensor Enabled - P130026/S070
- Class I Recall: North American Diagnostics Recalls Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits That Are Not Authorized, Cleared, or Approved by the FDA
- MQSA National Statistics (Updated)
July 29, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Labcorp Seasonal Respiratory Virus RT-PCR Test (Laboratory Corporation of America (Labcorp))
- Labcorp Seasonal Respiratory Virus RT-PCR DTC Test (Laboratory Corporation of America (Labcorp))
- Labcorp SARS-CoV-2 & Influenza A/B Assay (Laboratory Corporation of America (Labcorp))
- Lucira CHECK-IT COVID-19 Test Kit (Lucira Health, Inc.)
- Lucira COVID-19 All-In-One Test Kit (Lucira Health, Inc.)
July 28, 2022
- Class I Recall: Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub Defect
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210032 added)
July 27, 2022
- Laser-Assisted In Situ Keratomileusis (LASIK) Lasers - Patient Labeling Recommendations - Draft Guidance for Industry and Food and Drug Administration Staff
- Updated CDRH Learn Module: How to Get Your Electronic Product on the U.S. Market
- Federal Register: Laser-Assisted In Situ Keratomileusis Lasers: Patient Labeling Recommendations
July 26, 2022
- Meeting materials for July 28-29, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
- Notifications and Emergency Use Authorizations: FAQs on Testing for SARS-CoV-2 (Updated)
July 25, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Color COVID-19 Self-Swab Collection Kit (Color Health)
- PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 (PerkinElmer, Inc)
- Nexus High Throughput SARS-CoV-2 Assay (Nexus Medical Labs, LLC)
- QuickVue At-Home OTC COVID-19 Test (Quidel Corporation)
- MaximBio ClearDetect COVID-19 Antigen Home Test (Maxim Biomedical, Inc.)
- T-Detect COVID Test - (Adaptive Biotechnologies Corporation)
- Updated Emergency Use Authorizations
July 22, 2022
- Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices - Guidance for Industry and Food and Drug Administration Staff
- Co-sponsored Public Workshop - Expediting Innovation of Bioelectronic Implants for Vision Restoration, October 24-25, 2022
- Federal Register: Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices
July 21, 2022
- New Emergency Use Authorizations
- Reissued Emergency Use Authorizations
- Revoked Emergency Use Authorizations
- Amazon Real-Time RT-PCR DTC Test for Detecting SARS-CoV-2 (STS Lab Holdco (a subsidiary of Amazon.com Services LLC))
- Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR DTC Test STS Lab Holdco (a subsidiary of Amazon.com Services LLC))
- Amazon Multi-Target SARS-CoV-2 Real-Time RT-PCR Test (STS Lab Holdco (a subsidiary of Amazon.com Services LLC))
- Federal Register: Emergency Use Authorization: Certain Medical Devices during COVID-19
- Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication
July 20, 2022
- iHealth Labs, Inc.: iHealth COVID-19 Antigen Rapid Test (Updated Expiration Date)
- Class I Recall: Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion Delivery
- 24 Hour Summary for July 12-13, 2022 Patient Engagement Advisory Committee Meeting
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN200035 added)
July 19, 2022
- Supplies of Medical Devices for COVID-19: Frequently Asked Questions (Updated)
- Medical Device Shortages During the COVID-19 Public Health Emergency (Updated)
- Medical Device Types to Help Determine Section 506J Notification Obligations (Updated)
- Medical Gowns (Updated)
- Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar (Updated)
- At-Home OTC COVID-19 Diagnostic Tests (SD Biosensor updated)
July 18, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use AUthorizations
- Updated Emergency Use Authorizations
- Tracking Your Premarket Submission’s Progress (Progress Tracker) (Updated)
July 15, 2022
- Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication
- CDRH Petitions (Updated)
- Presentations for July 12-13, 2022 Patient Engagement Advisory Committee Meeting
July 14, 2022
- SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (Updated)
- Class I Recall: American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for Risk of False Results
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210045 added)
July 13, 2022
- Revised Emergency Use Authorizations
July 12, 2022
- New Emergency Use Authorization
July 11, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Updated Emergency Use Authorizations
- SalivaDirect At-Home Collection Kit (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
- SalivaDirect DTC Saliva Collection Kit (Yale School of Public Health, Department of Epidemiology of Microbial Diseases)
- Procleix SARS-CoV-2 Assay (Grifols Diagnostic Solutions, Inc.)
- Abbott RealTime SARS-CoV-2 (Abbott Molecular Inc.)
July 8, 2022
- Meeting Materials for July 12-13, 2022 Patient Engagement Advisory Committee Meeting
- 510(k) Third Party Review Organization Performance Report FY22 - Q3
July 7, 2022
- Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - July 27 and August 24
- Webcast Links for July 28-29, 2022 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
July 6, 2022
- Class I Recall: Getinge USA Sales Inc Recalls Flow-c and Flow-e Anesthesia Systems for Cracked or Broken Suction System Power Switches
- MedSun Newsletter - July 2022
July 5, 2022
- Updated Emergency Use Authorizations
- At-Home OTC COVID-19 Diagnostic Tests (InBios International and SD Biosensor updated)
- Pruebas de COVID-19 sin receta médica o de venta libre para diagnóstico en el hogar (InBios International and SD Biosensor actualizado)
- Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN210004 added)
- Federal Register: Public Advisory Panels of the Medical Devices Advisory Committee
June 30, 2022
- Personal Protective Equipment EUAs - Appendix A: Authorized Surgical Masks (Updated)
- Mammography Facilities with Revoked MQSA Certificate (Capitol Radiology, LLC 06-30-22)
- Mammography Facility Adverse Event and Action Report - June 30, 2022: Capitol Radiology, LLC doing business as Laurel Radiology Services
- Mammography Facility Adverse Event and Action Report - June 30, 2022: Medical University of South Carolina Hollings Cancer Center - Mobile Health Unit
- Update: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication
June 29, 2022
- Reissued Emergency Use Authorizations
- Revised Emergency Use Authorizations
- Medical Device Single Audit Program (MDSAP) (Updated)
- Federal Register: Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers
June 28, 2022
- Class I Recall: GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down
- Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication
- CDRH Petitions (Updated)